6533b7d3fe1ef96bd1260c58
RESEARCH PRODUCT
Ensuring the Consistency of Biosimilars
Juan V. EspluguesLoreto CarmonaAna Blas-garciaAna Blas-garciaIsabel Andujar PerezIsabel Andujar Perezsubject
Quality Controlmedia_common.quotation_subjectBiologíaScientific literature0603 philosophy ethics and religion03 medical and health sciencesPatient safety0302 clinical medicineConsistency (negotiation)Order (exchange)Drug DiscoveryHumansQuality (business)030212 general & internal medicineBiosimilar Pharmaceuticalsmedia_commonPharmacologyMedicamentoManufacturing processTumor Necrosis Factor-alphaBiosimilar06 humanities and the artsRisk analysis (engineering)Control de calidadMedicamentosNarrative review060301 applied ethicsBusinessCalidaddescription
Background: Biological products are subject to constant reappraisal by regulatory agencies and pharmaceutical companies once they have entered the market, since every improvement in their manufacturing process has the potential to alter the basic properties of these molecules. Methods: Narrative review focusing on scientific literature as well as legal documents from regulatory agencies. Results: Evaluating the impact of each manufacturing change of these drugs requires rigorous analyses in proportion to the anticipated risk of inducing more or less molecular micro-heterogenicity. There are currently more than 30 biosimilars of TNF-alpha blockers at different stages of testing, each with a specific manufacturing process. Although the initial demonstration of biosimilarity is now a well-established exercise, it does not guarantee that successive manufacturing changes will not result in a widening gap between drifted/evolved innovators and drifted/evolved biosimilars, as well as among the different biosimilars of a given original biologic. Conclusion: Given the structural complexity of TNF-alpha blockers-as well as of other biologic drugs included in the armamentarium of systemic inflammatory diseases-regulatory agencies should make available to the practitioner, in a simple and constantly updated way, all available data regarding quality standards of both original molecules and biosimilars. Furthermore, they should strive to guarantee that, once a compound has received approval, it maintains a level of consistency throughout its commercial life in order to maintain and increase confidence in these valuable drugs. Sin financiación 2.757 JCR (2017) Q2, 114/261 Pharmacology & Pharmacy UEM
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2017-10-29 |